Midweek update

Mental health care

Midweek update

David Ermer–Congress, COVID treatment, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Obesity, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Roll Call informs us
    • “House leadership smoothed the path for consideration of a $78 billion family and business tax break deal Wednesday by committing to a floor vote as soon as next week on a separate bill to boost the state and local tax deduction cap for married couples.”
  • and later
    • “The House on Wednesday night passed a $79 billion family and business tax break bill after several days of uncertainty, teeing it up for consideration in the Senate. 
    • “The package negotiated by House Ways and Means Chairman Jason Smith, R-Mo., and Senate Finance Chair Ron Wyden, D-Ore., easily mustered the two-thirds majority needed to pass, despite GOP drama earlier in the week and previous criticism from Democrats. 
    • “It’s a strong, commonsense, bipartisan step forward in providing urgent tax relief for working families and small businesses,” Smith said on the floor ahead of the 357-70 vote. “Parents in Main Street communities across this country will see lower taxes, more opportunity and greater financial security after we pass this legislation.”
  • Here is a link to today’s hearing held by the House Energy and Commerce Committee’s Health Subcommittee about national healthcare expenditures.
  • Fierce Healthcare tells us,
    • “Medicare Advantage (MA) payments are set to decrease yet again in 2025 as the feds phase in significant changes to risk adjustment.
    • “As those overhauls begin to take effect, benchmark payments are set to decline by about 0.2% on average, according to the latest advance notice released by the Centers for Medicare & Medicaid Services (CMS).
    • “Despite this, the feds said Wednesday that payments to MA plans are expected to increase by 3.7% in 2025, a $16 billion increase over 2024. The payment rate announced today could change by the time the final rate announcement is published, no later than April 1.”
  • The CY 2025 Advance Notice may be viewed by going to: https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Announcements-and-Documents and selecting “2025 Advance Notice.”
  • A fact sheet discussing the provisions of the CY 2025 Advance Notice, as well as frequently asked questions, can be viewed here: https://www.cms.gov/newsroom/fact-sheets/2025-medicare-advantage-and-part-d-advance-notice-fact-sheet.
  • Beckers Payer Issues adds,
    • “A bipartisan group of lawmakers is urging CMS to maintain “payment and policy” stability in Medicare Advantage. 
    • “In a letter to CMS Administrator Chiquita Brooks-LaSure, the group of 60 senators asked the agency to “consider the ongoing implementation of program reforms finalized last year and provide stability for the Medicare Advantage program in 2025.”  * * *
    • “The letter comes after two lawmakers, Sen. Elizabeth Warren and Rep. Pramila Jayapal, wrote to the agency urging more action on curbing overpayments to the program. 
    • “Read the full letter here. “
  • Today, OPM posted on the Federal Register website a proposed FEHB rule that “would allow FEHB and PSHB coverage to become effective at the beginning of the pay period that the employee in pay status has an initial opportunity to enroll. This change would occur when the employee becomes eligible for FEHB or PSHB coverage, provided an appropriate request to enroll is received by the employing office within the initial pay period that the employee becomes eligible.”
  • American Hospital News reports,
    • “The Substance Abuse and Mental Health Services Administration Jan. 31 issued a final rule that updates certain regulations for Opioid Treatment Programs and the standards for treatment of opioid use disorder. The rule makes some COVID-19-related flexibilities permanent, including take-home doses of methadone, the ability of an OTP to prescribe medication for OUD via telehealth without an initial in-person physical evaluation, and the removal of certain requirements for admission to an OTP to better align with evidence-based practice.”
  • KFF shares three charts about Medicare drug price negotiations.
  • Federal News Network reports,
    • “The Postal Service is looking to cut $5 billion from its operating costs and grow its revenue by the same amount over the next two years to overcome its long-term financial challenges.
    • “Postmaster General Louis DeJoy is telling the White House and Congress that implementing these plans is necessary to keep USPS from running out of cash in the coming years.
    • “DeJoy, in a Jan.10 letter obtained by Federal News Network, told President Joe Biden and congressional leaders that USPS is “utilizing all of the self-help tools that are available to us,” and trying to get back on track with its “break-even” goal, after years of billion-dollar net losses.
    • “It is evident that to break even and avoid running out of cash in the next several years, we must press ahead on our financial improvement initiatives over the next two years,” DeJoy wrote. “While we have already achieved historic reductions, they are simply not enough to make us financially sustainable.”

From the public health and medical research front,

  • Check out this JAMA Open article to learn why “Paxlovid Is Effective but Underused—Here’s What the Latest Research Says About Rebound and More.”
  • Per Fierce Healthcare,
    • “As artificial intelligence advances in different areas of healthcare, there are concerns that technology and AI-based chatbots will replace the human connections between patients and practitioners.
    • “But, a new study finds promising potential for AI and large language models to enhance mental health therapy at scale by being able to analyze millions of text-based counseling messages to shine a light on what works.
    • “Researchers used AI to analyze more than 20 million text conversations of counseling sessions and successfully predicted patient satisfaction and clinical outcomes, according to a study published this week in the Journal of The American Medical Association (JAMA) Open.”
  • The National Institutes of Health announced,
    • An analysis conducted by the National Institutes of Health’s National Center for Complementary and Integrative Health (NCCIH) reveals a substantial increase in the overall use of complementary health approaches by American adults from 2002 to 2022. The study, published in the Journal of the American Medical Association, highlights a surge in the adoption of complementary health approaches for pain management over the same period.
    • Researchers utilized data from the 2002, 2012, and 2022 National Health Interview Survey (NHIS) to evaluate changes in the use of seven complementary health approaches, including yoga, meditation, massage therapy, chiropractic care, acupuncture, naturopathy, and guided imagery/progressive muscle relaxation.
    • The key findings include:
      • The percentage of individuals who reported using at least one of the seven approaches increased from 19.2% in 2002 to 36.7% in 2022.
      • The use of yoga, meditation, and massage therapy experienced the most significant growth from 2002 to 2022.
      • Use of yoga increased from 5% in 2002 to 15.8% in 2022.
      • Meditation became the most used approach in 2022, with an increase from 7.5% in 2002 to 17.3% in 2022.
      • Acupuncture, increasingly covered by insurance, saw an increase from 1% in 2002 to 2.2% in 2022.
    • Additionally, the analysis showed a notable rise in the proportion of U.S. adults using complementary health approaches specifically for pain management. Among participants using any of the complementary health approaches, the percentage reporting use for pain management increased from 42.3% in 2002 to 49.2% in 2022.
    • Despite the findings, the authors acknowledge study limitations, including decreasing NHIS response rates over time, possible recall bias, cross-sectional data, and differences in survey wording.
  • and
    • “Researchers at the National Institutes of Health detected abnormal proteins in the spinal fluid of people with amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD), which could help improve diagnosis of these diseases. The findings were published in Science Translational Medicine.
    • “The proteins in question are built from “cryptic” exons—abnormal portions of RNA, the cell’s instructions for how to build proteins. Cryptic exons occur when TDP-43, a protein that regulates how RNA is processed, stops functioning normally. TDP-43 dysfunction is linked to ALS, FTD, Alzheimer’s disease, and Limbic Associated TDP-43 Encephalopathy (LATE).
    • “The study showed that these mis-spliced sections of RNA can sometimes generate new proteins from the cryptic sequence. The findings advance our understanding of how cryptic exons may be involved in the dementia disease process and could help identify diseases involving TDP-43 dysfunction before symptoms appear. Currently, TDP-43 aggregates in the brain can only be detected at autopsy.”  
  • MedPage Today points out, “Getting clinicians to commit to the Choosing Wisely recommendations somewhat reduced low-value care for older adults in common scenarios, a cluster randomized trial found.”

From the U.S. healthcare business front,

  • Per BioPharma Dive,
    • “Novo Nordisk has resumed shipping starter doses of its weight-loss drug Wegovy, nearly nine months after manufacturing problems forced it to restrict distribution to maintenance shots in order to ensure that people who had already started taking it could continue, the company said Wednesday.
    • “The resumption of the starter doses, which begin at 0.25 milligrams per week, comes two months after obesity rival Eli Lilly gained U.S. approval for a competing drug, Zepbound, that could threaten to eat away at Novo’s sizable lead in weight-loss treatment.”
  • The Wall Street Journal adds,
    • “Nearly every employer in the country is now grappling with how—and whether—to pay for new weight loss drugs. Needless to say, such decisions are highly important to patients struggling with obesity.
    • “But for Eli Lilly and Novo Nordisk, it actually doesn’t matter, for now, from a financial perspective. They are selling every injection they can make. It won’t change anytime soon.” ***
    • While the companies are both moving as fast as possible, expanding the manufacturing of injectables is complicated. 
    • “You’re talking about billions of pens. That’s not a trivial exercise,” says Guggenheim analyst Seamus Fernandez. “Producing pens is a very complex process that requires precision and lots of attention to safety.” 
    • “That is one reason why developing pills such as Lilly’s orforglipron, which is undergoing clinical trials, is so crucial, he adds. Figuring out how to make oral versions well-tolerated is a challenge, though.”
  • MedTech Dive tells us about the top medtech trends in 2024. “Experts said M&A, orthopedic procedure backlogs and emerging cardiac markets were among the top trends to watch in the medical device industry this year.”
  • Per Healthcare Dive,
    • “Cigna has agreed to sell its Medicare business to Health Care Service Corporation for roughly $3.7 billion, the health insurer announced Wednesday.
    • “HCSC is acquiring Cigna’s Medicare Advantage, supplemental benefits and Medicare Part D plans, along with CareAllies, a division that helps providers transition to value-based care. In total, the plans cover 3.6 million people on Medicare.
    • “The companies said they expect the deal — which includes $3.3 billion in cash and $400 million in capital Cigna expects to be freed up — to close in the first quarter of 2025, subject to regulatory approval.”
  • and
    • “Humana plans to expand its primary care network for seniors this year, as the insurer looks to lean on provider capabilities to boost its beleaguered Medicare Advantage business.
    • “In 2024, CenterWell Senior Primary Care plans to enter three new markets in North Carolina and Louisiana, and add additional centers in eight of its current markets in the U.S., the payer announced on Tuesday.
    • “Humana is one of many health insurers racing to build out a provider network to provide convenient access to primary care for its members. But for Humana, this strategy is more important than it might be for its rivals with a broader variety of plans, given Humana has made such a significant bet on Medicare Advantage, said Arielle Trzcinski, a healthcare analyst at market research firm Forrester.”
  • BioPharma Dive lets us know,
    • In 2021, the Food and Drug Administration for the first time approved a medicine meant to slow the progression of Alzheimer’s disease. Developed by partners Biogen and Eisai, the medicine, called Aduhelm, was viewed initially as a needed new treatment option by patients and a potential blockbuster product by Wall Street analysts.
    • “Now, less than three years since that approval, Biogen is fully giving up on the drug. The company said Wednesday it is handing rights to back to Aduhelm’s original developer, Neurimmune, and will redirect much of the money spent on the drug toward other Alzheimer’s therapies in its business.
    • “Biogen is reprioritizing resources to build a leading franchise to address the multiple pathologies of the disease and patient needs,” said Christopher Viehbacher, the company’s CEO, in a statement.”
  • Per Beckers Payer Issues,
    • “The share of U.S. employees in healthcare plans funded by their employer rose from 2015 to 2021, a study published in the January issue of Health Affairs found. 
    • “In 2015, 55% of employees were enrolled in self-funded plans, compared to 60% of employees in 2021. Most of the growth occurred in states and counties with lower levels of self-funded enrollment, the study found. 
    • “Groups of rapid growth in self-funded plans were concentrated in Arkansas, New York, Northern California, Pennsylvania and Utah, the study found. 
    • “Elevance Health is the largest administrator of self-funded plans, with around 19% of the total market, according to the study. CVS Health claimed the fastest growing self-funded enrollment from 2015 to 2021. “

Thursday Miscellany

David Ermer–CMS, Congress, COVID-19, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Politico reports,
    • “The House cleared a stopgap spending bill on Thursday afternoon that officially keeps federal agencies funded through early March, sending the measure to President Joe Biden’s desk. * * *
    • “With parts of the government now funded through March 1 and March 8, leading appropriators have a tremendous amount of work to do in just a matter of weeks. ***
    • “Haggling over the broader spending bills can’t begin in earnest, however, until leading appropriators lock down a deal on funding totals for all 12 of them. It’s a critical next step that has consumed the last couple weeks for Senate Appropriations Committee Chair Patty Murray (D-Wash.) and her House counterpart, Chair Kay Granger (R-Texas).”
  • The American Hospital News informs us,
    • “The Departments of Health and Human Services, Labor, and the Treasury will reopen the public comment period for their proposed rule to improve the No Surprises Act independent dispute resolution process for 14 days beginning Jan. 22 to provide additional time for interested parties to comment.”
  • The Center for Medicare and Medicaid Services announced the Innovation in Behavioral Health (IBH) Model.
    • IBH is focused on improving quality of care and behavioral and physical health outcomes for Medicaid and Medicare populations with moderate to severe mental health conditions and substance use disorder (SUD). Medicare and Medicaid populations experience disproportionately high rates of mental health conditions and/or substance use disorders (SUD), and as a result are more likely to experience poor health outcomes and experiences, like frequent visits to the emergency department and hospitalizations, or premature death. 
    • The IBH Model seeks to bridge the gap between behavioral and physical health; practice participants under the IBH Model will screen and assess patients for select health conditions, as well as mental health conditions and/or SUD, in community-based behavioral health practices. IBH is a state-based model, led by state Medicaid Agencies, with a goal of aligning payment between Medicaid and Medicare for integrated services.
    • CMS will release a Notice of Funding Opportunity (NOFO) in Spring 2024, and up to eight states will be selected to participate. The model will launch in Fall 2024 and run for eight years.
  • The Department of Health and Human Services also issued a fact sheet about steps taken over the last year to expand access to behavioral health by integrating behavioral health with primary care and other physical health and community settings.
  • The U.S. Preventive Services Task Force posted a draft research plan concerning “BRCA-Related Cancer: Risk Assessment, Genetic Counseling, and Genetic Testing” for public comment. The public comment deadline is February 14, 2024.

From the public health and medical research front

  • The Kaiser Family Foundation discusses the two healthcare cost crises facing our country.
    • “The cost of health care isn’t a single problem, it’s a multi-dimensional one. That’s one reason we often talk past each other about healthcare costs; we’re talking about different problems. There’s national health spending, consumer out-of-pocket costs, federal health spending (mostly for Medicare and Medicaid), state health spending (mostly Medicaid), employer premiums, and the cost problem currently in vogue—getting better “value” for the health care dollar. Like a Venn diagram with sets that don’t always overlap, each of these are different challenges that often have different and sometimes conflicting solutions. We work on all of these dimensions of health care costs at KFF, but two health cost problems stand out as legitimate health policy crises: Affordability, especially for people who are sick and need a lot of healthcare, and national health spending (the subject of the CMS annual report).”
  • STAT News reports,
    • Mental health care in the United States is in crisis. As the need for care surges — a longstanding trend exacerbated by the Covid-19 pandemic — the demand for therapists far outstrips the supply. In national surveys, more than one in five U.S. adults suffer from mental illness, yet almost half of those in need report receiving no care. People struggling with mental health challenges often spend months on a wait list despite needing immediate care. Others simply can’t afford it. And getting care is even harder for people living in rural areas and people of color. * * *
    • In the face of these issues, there’s growing interest in the use of lay counselors. One scientific journal recently announced a call for papers for a special issue on the subject. In its executive summary for a recent population health summit, the APA [American Psychological Association] declared that the “exclusive reliance on trained mental health care providers when there are severe gaps in support for training of a mental health workforce has left millions untreated.” A number of recent research articles suggest addressing the gap by innovating on the traditional model of mental health treatment, including where and how it is provided and who provides it.
    • Lynn Bufka, associate chief of practice transformation and quality at the APA, believes that an expanded approach to providing mental health care is essential to meet the current need. “We clearly cannot meet the need for mental health services in this country with the existing workforce,” she said. “We’re going have to consider those kinds of models and options in order to get to where we need to be in this country.”
  • STAT New also delves into whether recent scientific findings may lead to a test for long Covid.
    • “Long Covid has long eluded scientists looking for its cause. Not knowing what triggers its persistent and distressing symptoms makes the condition challenging to treat; it’s hard to even say definitively who has it. New research published Thursday in Science has identified proteins present in the blood of people with long Covid that could point the way to a much-needed diagnostic test and possibly to future therapeutic targets.
    • “Scientists at the University of Zurich discovered high levels of proteins involved in the complement system — an important part of the immune system bridging innate and adaptive responses — that were disrupted in people with long Covid symptoms, but not in those who got better after the initial Covid-19 infection or in those who had recovered from long Covid symptoms after six months. The team also found damaged red blood cells and platelets as well as signs of harm to the endothelial cells that line blood vessels.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Drugmakers kicked off 2024 by raising the list prices for Ozempic, Mounjaro and dozens of other widely used medicines. Companies including the maker of Ozempic, and Eli Lilly , which sells Mounjaro, raised list prices on 775 brand-name drugs during the first half of January, according to an analysis for The Wall Street Journal by 46brooklyn Research, a nonprofit drug-pricing analytics group. 
    • “The drugmakers raised prices of their medicines by a median 4.5%, though the prices of some drugs rose by around 10% or higher, according to the research group. The median increase is higher than the rate of inflation, which ticked up to 3.4% in December. * * *
    • “Among the notable increases: The price for Ozempic, a diabetes treatment that many people are taking to lose weight, went up by 3.5% to nearly $970 for a month’s supply. Mounjaro, a diabetes drug in the same class that is also widely used for weight loss, climbed 4.5% to almost $1,070 a month.”
  • Healthcare Dive identifies “Top healthcare trends in 2024; Here’s what industry experts see coming down the pike for hospitals, insurers and digital health companies this year.” The article summarizes Healthcare Dive’s 2024 trend reports from the past few weeks.
  • Healthcare Dive also informs us,
    • “Humana is the latest victim of elevated medical costs in the fourth quarter. The health insurer on Thursday lowered its 2023 profit outlook after members utilized more healthcare than expected as the year drew to a close.
    • “Humana now expects $26.09 in adjusted earnings per share for full-year 2023, according to a financial filing. That’s down from its prior guidance of at least $28.25.
    • “Humana also lowered its expectations for growth in the lucrative Medicare Advantage program. The insurer now expects to increase MA membership 1.8% this year. Previously, Humana said it would outstrip expected industry growth of 6% to 8%.”
  • CVS Health posted a report highlighting opportunities for the future of community pharmacies.

Tuesday Tidbits

David Ermer–AHRQ, Congress, FDA, Mental health care, NIH, No Surprises Act, Obesity, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • Roll Call tells us,
    • “The Senate overwhelmingly voted Tuesday night in favor of the first procedural move needed to avert a partial government shutdown at the end of this week.
    • “The chamber voted 68-13 to end debate on the motion to proceed to the shell legislative vehicle for the stopgap spending measure, which would run to March 1 for four of the dozen annual appropriations bills and until March 8 for the remaining eight.
    • “Leadership in both chambers are in favor of the stopgap measure, which is designed to give appropriators more time to negotiate final fiscal 2024 appropriations bills following the $1.66 trillion topline agreement Speaker Mike Johnson, R-La., and Senate Majority Leader Charles E. Schumer, D-N.Y., announced earlier this month.”
  • Roll Call further informs us,
    • “Congressional leaders and key committee heads are poised to meet with the president at the White House Wednesday to discuss the national security supplemental package that has remained stalled over the lack of agreement on border and immigration policy measures.
    • “White House Press Secretary Karine Jean-Pierre confirmed President Joe Biden’s plans to host the meeting during a Tuesday briefing. 
    • “Speaker Mike Johnson, R-La., House Minority Leader Hakeem Jeffries, D-N.Y., Senate Majority Leader Charles E. Schumer, D-N.Y., and Senate Minority Leader Mitch McConnell, R-Ky., are expected to attend the meeting.”
  • The Wall Street Journal adds,
    • “Top U.S. lawmakers unveiled a bipartisan tax agreement that would revive expired breaks for businesses and increase the child tax credit for low-income families, and they are aiming to push the $78 billion in tax breaks through Congress in the next few weeks. 
    • “The deal comes from Sen. Ron Wyden (D., Ore.) and Rep. Jason Smith (R., Mo.), ideological opponents who found common ground after months of talks. They have a tough task ahead, given skepticism about aspects of the deal in both parties and a tight deadline before tax season starts.”
  • Roll Call notes,
    • “The conservative-controlled Supreme Court could upend how courts handle challenges to the decisions administrative agencies make, in a pair of cases set for oral arguments Wednesday that could change the standards for how Congress writes laws and the federal government implements them.
    • “The challengers to a fishery inspection rule asked the justices to overturn the Chevron doctrine, a nearly 40-year-old legal framework based on a Supreme Court decision that established that judges should defer to the agencies’ interpretations of a law when that law is ambiguous.
    • “Parts of the conservative legal movement have targeted the doctrine for years, casting it as emblematic of the broader power of administrative agencies, and Wednesday’s oral arguments could preview its demise.”
  • STAT News reports,
    • “President Biden has promised to require fair prices from drugmakers that use federally funded research — and now, in a major recent move, said he’ll trigger government “march-in” on patents for drugs that run afoul of that goal.
    • “It’s a simple principle. You shouldn’t pay the highest price in the world for drugs that your tax dollars have already helped create,” Biden said last month as he touted the move at the National Institutes of Health.
    • “But the new NIH director, locked in the center of this debate, isn’t taking any big steps yet.
    • “Our relationship with the pharmaceutical industry, with the industry overall, is really, really critical,” Director Monica Bertagnolli told STAT in an interview. “It’s very difficult, if you can imagine, to implement something broadly that is as effective as we want it to be.”
  • KFF Health News reports that a new federal program to save rural hospitals is experiencing growing pains.
  • The U.S. Preventive Services Task Force announced the appointment of three new members, “Sei Lee, M.D., M.A.S.; Tonette Krousel-Wood, M.D., M.S.P.H.; and Sarah Wiehe, M.D., M.P.H. They are appointed to serve 4-year terms beginning in January 2024.”
  • The National Academies of Science announced,
    • “A new report from the National Academies of Sciences, Engineering, and Medicine says 15 health care services related to intimate partner violence — including reproductive health care, screening for STIs and HIV, forensic medical exams, and mental health care — should be classified by the Health Resources and Services Administration and all U.S. health care systems as essential healthcare services. The report recommends prioritizing access to these healthcare services during public health emergencies, such as a pandemic or natural disasters, using a phased approach.”  
  • Per Forbes,
    • “The FDA approved the use of Casgevy, a therapy that uses CRISPR gene-editing to treat the serious blood disorder transfusion-dependent beta-thalassemia, marking the second major U.S. regulatory approval for the emerging gene-editing technology. The FDA’s approval comes just one month after the regulator approved the use of Casgevy in treating sickle cell disease.”

From the public health and medical research front,

  • Health Day points out,
    • “Despite overall progress against cancer in the United States, Black Americans are still more prone to die of the disease than whites
    • “Data from 2000 to 2020 showed the racial gap in cancer deaths had diminished but was still significant.
    • “Disparities in deaths from breast cancer, prostate cancer and colon cancer in men were especially troubling.”
  • Healthcare IT News explains why “Virtual group therapy enables Geisinger to treat more patients and maintain care continuity. With waits for individual psychotherapy as long as several months and several thousand outstanding orders, the mostly rural health system needed a solution. Combining group therapy and telemedicine [with help from American Well] was the answer.”
  • STAT News reports,
    • “Last fall, the World Health Organization and some national drug regulators urged influenza vaccine manufacturers to drop the component known as B/Yamagata from flu vaccines as quickly as possible, citing the fact that this lineage of flu B viruses appears to have been snuffed out during the Covid-19 pandemic.
    • “It might seem like that request would be as simple as deciding to leave blueberries out of a mixed-fruit smoothie. It turns out it is not.”

From the U.S. healthcare business front,

  • Healthcare Dive discusses trends shaping the health insurance business in 2024.
  • Via Fierce Healthcare, Morgan Health offers three items employers should focus on to manage GLP-1 drug costs.
  • Bloomberg informs us about lawsuits that air ambulance companies have brought against health insurers who allegedly refused to pay No Surprises Act arbitration awards. The insurers have asked the federal district court in Houston to dismiss the cases for lack of subject matter jurisdiction and improper venue.
  • Beckers Hospital Review lets us know,
    • “The Mayo Clinic Diet, a weight loss program developed by the Rochester, Minn.-based health system, is launching a weight loss telemedicine service.
    • “The Mayo Clinic Diet Medical Weight Loss Rx program will offer direct access to weight loss medications, or GLP-1s, via video visits with Amwell Medical Group clinicians, according to a Jan. 16 news release shared with Becker’s.
    • “The program, which is available in beta form to qualifying members, will also provide lab testing to confirm medication suitability, clinical monitoring, insurance support, meal plan options, and coaching and education tools.”
  • Beckers Payer Issues tells us,
    • “Though some contract negotiations with providers came “down to the wire” last year, UnitedHealthcare executives said the payer did not see more contract splits than usual in 2023. 
    • “Brian Thompson, CEO of UnitedHealthcare, told investors on a Jan. 12 call the insurer did not see more contract disruptions than in previous years in 2023.” 

 

Monday Roundup

David Ermer–Congress, Medical / Rx research, Mental health care, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington DC,

  • Roll Call reports, “As the calendar turns to a presidential election year with control of both chambers in play, Congress and the White House are facing a full slate of leftovers from 2023, headlined by a stalled emergency supplemental spending request and looming deadlines to keep the government open.”
  • The Wall Street Journal adds,
    • “House Speaker Mike Johnson (R., La.) now has less than two weeks to pass spending legislation needed to avert a partial government shutdown, while contending with many of the same challenges that ultimately took down his predecessor three months ago.
    • “Following a deal with the Democratic-led Senate announced over the weekend, Johnson will try to rally his fellow Republicans this week around a plan for $1.66 trillion in overall discretionary spending for fiscal 2024.   
    • “While Democrats have largely signaled their support for the agreement, hard-line conservatives have blasted the top-line figure, meaning that Johnson almost certainly will have to rely on Democratic votes to pass the measure in the House, where the GOP has a narrow 220-213 majority. Former speaker Kevin McCarthy (R., Calif.) was able to muscle through a short-term spending bill in September and avert a government shutdown, only for eight Republican rebels to then engineer his ouster.
    • “Johnson noted Sunday that he now has an even smaller majority than when McCarthy was the speaker. “We deal with the numbers that we have,” Johnson said on  CBS. “It will be one of the smallest majorities in the history of the Congress, clearly.”
    • “The speaker backed a short-term deal late last year to avoid a Christmas showdown over spending. New deadlines of Jan. 19 and Feb. 2 are now before him, providing the biggest test of his still-fledgling speakership and his ability to wrangle his unruly GOP conference.”
  • Good luck, Mr. Speaker.
  • The American Hospital Association News tells us,
    • “Health and Human Services Secretary Xavier Becerra Jan. 8 appointed as chief competition officer Stacy Sanders, who currently oversees the department’s implementation of the Inflation Reduction Act, long-term care initiatives, policies to promote health care competition and other Medicare work. In this new role, announced by the Biden Administration last month, Sanders will work with the Federal Trade Commission and Department of Justice to address concentration in healthcare markets through data-sharing, reciprocal training programs, and other policy initiatives.”

From the public health and medical research front,

  • Endpoint News informs us,
    • “The crown jewel from Bayer’s 2020 buyout of women’s health biotech KaNDy Therapeutics has proven its worth in the clinic, meeting all primary and secondary endpoints in a pair of Phase III studies.
    • “Bayer says it plans to file the drug, elinzanetant, for regulatory approvals to treat moderate to severe vasomotor symptoms associated with menopause once results from a third Phase III study are in. Those data are expected within the next few months.
    • “Elinzanetant, formerly known as NT-814, hit all four primary endpoints in the OASIS 1 and 2 studies, showing statistically significant reductions in the frequency and severity of VMS symptoms — also known as hot flashes. The company didn’t report any numbers, but it said the drug also did better than placebo on a slate of secondary endpoints, including frequency of VMS at week 1, improvement of sleep disturbance and menopause-related quality of life.”
  • The Institute for Clinical and Economic Review (ICER) released a Final Evidence Report on Treatment for Pulmonary Arterial Hypertension.
    • ICER’s “Independent appraisal committee voted that sotatercept demonstrated a net health benefit when compared to background therapy; sotatercept would achieve common thresholds for cost-effectiveness if priced between $17,900 to $35,400 per year.
  • The Washington Post and Consumer Reports points out “quick fixes for congestion, sneezing and other sinus woes.”

From the U.S. healthcare business front,

  • The National Institutes of Health announced,
    • “Access to residential addiction treatment centers caring for U.S. adolescents under 18 years old in the United States is limited and costly, according to a new study(link is external) supported by the National Institutes of Health. Researchers found that only about half (54%) of the residential addiction treatment facilities that they contacted had a bed immediately available, and for those that had a waitlist, the average estimated time before a bed opened was 28 days. In addition, the average daily cost per day of treatment was $878, with close to half (48%) of the facilities that provided information requiring partial or full payment upfront. On average, the quoted cost of a month’s stay at a residential addiction treatment facility was over $26,000.
    • “Published in Health Affairs, this study was supported by the National Institute on Drug Abuse (NIDA) and the National Center for Advancing Translational Sciences (NCATS), both part of NIH, and led by researchers at Oregon Health & Science University (OHSU). The results build on previous research revealing that only one in four residential treatment centers caring for U.S. adolescents under 18 years old provide buprenorphine, a medication to treat opioid use disorder.
    • “The ability to access timely, evidence-based treatment for addiction can be a matter of life or death, and the current system too often fails young people,” said Nora Volkow, M.D., director of NIDA. “We need to make access to timely, affordable, and evidence-based care the norm across treatment settings.”
  • mHealth Intelligence takes a look at this year’s virtual care trends.
    • “The mood of healthcare stakeholders going into 2024 may be more somber than in the recent past, but the work of integrating virtual care into the US healthcare system is ongoing. Here [in the article] are some key trends healthcare leaders, policy experts, and consultants expect to see in the new year.”
  • MedTech Dive notes,
    • “Procedure volumes increased in the fourth quarter, mostly matching or exceeding the usual seasonal trend, according to Truist Securities’ survey of 50 U.S. hospital administrators.
    • “The survey suggests procedure volumes rose 2% to 3% over the third quarter, with interventional cardiology experiencing the biggest increase. The analysts wrote companies including Boston Scientific, Edwards Lifesciences and Medtronic would benefit from rising cardiology volumes.
    • “Truist also saw positive signs for Intuitive Surgical, tracking improvements in the outlook for capital spending and a rebound in weight loss procedures after pressure from obesity drugs.”
  • and
    • “Boston Scientific said Monday it has agreed to acquire Axonics, maker of devices to treat urinary and bowel dysfunction, for $3.7 billion in cash, or $71 per share.
    • “The acquisition allows Boston Scientific to enter the high-growth sacral neuromodulation market, where it will compete with companies such as Medtronic. 
    • “Stifel analyst Rick Wise, in a note to clients Monday, called the deal a highly complementary fit to Boston Scientific’s urology business, which generated about 14% of its estimated 2023 sales.”

Weekend Update

David Ermer–Congress, Cybersecurity, Medical / Rx research, Mental health care, OPM, SCOTUS, U.S. Healthcare–
Photo by JOSHUA COLEMAN on Unsplash

The FEHBlog was tied up with family business yesterday so Cybersecurity Saturday appears below the Weekend Update

From Washington, DC,

  • Congress is back to work on Capitol Hill. The Wall Street Journal describes the situation as “Battered Congress Has Two Weeks to Fix Three Big Problems: Talks to stop a government shutdown, fix the border and fund Ukraine converge on Capitol Hill.”
  • The Journal adds this evening,
    • “Congressional leaders reached a bipartisan deal on Sunday setting a roughly $1.6 trillion federal spending level for the year, but the pact drew quick criticism from some conservatives, and it remained unclear whether lawmakers would be able to quickly pass legislation averting a government shutdown.”
  • Congress does not have any hearings scheduled for this week.
  • The Washington Post reports,
    • “The Supreme Court said Friday it will review a case (No. 23-727) challenging Idaho’s strict abortion ban, which the Biden administration says conflicts with a federal law [EMTALA] requiring emergency room doctors to perform the procedure in some circumstances.”
  • Federal News Network provides more background to reduce retirement program overpayments.
    • “For OPM, many of the improper payments that the agency makes through retirement services may stem from limited data, on account of not using enough analytics to identify beneficiaries who have died and therefore are no longer entitled to the benefits, [Linda] Miller, [Audient Group CEO] said.
    • “There is more than one way of identifying people who have passed away — looking at Social Security, obituary data and more accurate information on deaths,” Miller said. “OPM doesn’t use much of that data, so the reports are likely less accurate.”

From the public health and medical research front,

  • Fortune Well offers us four strategies for older folks to get good quality sleep and an approach to adding beneficial thirty-second-long micro-workouts to your day.
  • Govexec tells us,
    • “The Veterans Affairs Department will soon begin funding research into the use of psychedelics such as MDMA and mushrooms to treat PTSD and depression, the first time the agency has done so since the 1960s. 
    • “The announcement answers the call from some veterans and researchers who have long advocated for the potential medical benefits of MDMA and psilocybin, or psychoactive mushrooms. VA on Friday issued a request for applications to its network of researchers, collaborating with academic institutions to solicit proposals to study the impact of using the compounds to treat post-traumatic stress disorder and depression in veterans.” 

From the U.S. healthcare front,

  • STAT News reminds us that the JP Morgan Healthcare Conference will be held this week in San Fransico.
    • “Nonprofit hospitals often get overshadowed at the J.P. Morgan Healthcare Conference, the health care industry’s swankiest investor meeting whose agenda is dominated by drugmakers and biotech companies.
    • “But hospitals are still the largest part of America’s health care economy, commanding nearly a third of the country’s $4.7 billion health care tab. And similar to last year, when hospitals touted their plans for expansion and hiking prices, they will have a rosy picture to sell to financiers as patients flock to their facilities.”
  • The American Medical Association informs us, “What doctors wish patients knew about scope of practice.”
  • Health Payer Intelligence points out,
    • “Despite efforts to reduce drug costs through Medicare negotiation for 10 common medications, the US still pays more for these drugs than almost any other nation, even after factoring in discounts and rebates, according to a Commonwealth Fund chart pack.
    • “The researchers used 2021 data from IQVIA and the Medicare Payment Advisory Commission (MedPAC) to assess how US drug prices differed from international trends. With this information, the researchers compiled 12 charts that situate the drug prices in the United States compared to other countries.”
  • Per Fierce Healthcare,
    • “Duluth, Minnesota-based Essentia Health and Marshfield, Wisconsin-based Marshfield Clinic Health System have scrapped their plan to merge into a 25-hospital Midwest system.
    • “The two nonprofit health systems said in a statement that they have “engaged in meaningful discussion” over the last two years about how the organizations could combine their unique strengths.
    • “We have decided that a combination at this time is not the right path forward for our respective organizations, colleagues and patients,” the health systems said in a statement posted to Essentia Health’s website Friday.”
  • BioPharma Dive reports,
    • “Metagenomi, a biotechnology startup working to identify new CRISPR enzymes for editing genes, has filed to go public.
    • “Backed by healthcare investors and pharmaceutical firms including Novo Nordisk’s parent company and Bayer’s venture arm, Metagenomi most recently raised a $275 million Series B round. The startup is also partnered with Moderna and Ionis Pharmaceuticals.
    • “The Emeryville, California-based biotech is one of at least three life sciences companies to publicly plan for an initial public offering so far this year. Should it successfully price an IPO, its performance could serve as an early barometer for the sector in 2024.”
  • The Society for Human Resource Management notes HR trends for which we should be prepared in 2024

Cybersecurity Saturday

HealthcareIT Today offers a boatload of cybersecurity predictions for 2024.

From the cybersecurity vulnerabilities front,

  • HHS’s Health Sector Cybersecurity Coordination Center (HC3) released its December 2023 monthly vulnerabilities report on January 4:
    • In December 2023, vulnerabilities to the health sector have been released that require attention. This includes the monthly Patch Tuesday vulnerabilities released by several vendors on the second Tuesday of each month, along with mitigation steps and patches. Vulnerabilities for December are from Microsoft, Google/Android, Apple, Mozilla, Cisco, SAP, VMWare, Adobe, Fortinet, and Atlassian. A vulnerability is given the classification of a zero-day when it is actively exploited with no fix available or if it is publicly disclosed. HC3 recommends patching all vulnerabilities with special consideration to the risk management posture of the organization.”
  • The Cybersecurity and Infrastructure Security Agency added two more known exploited vulnerabilities to the catalog on January 2.
  • Cybersecurity Dive reported on January 5,
    • “A critical vulnerability in Apache OFBiz was hit with a surge in exploitation attempts in recent weeks, which could allow attackers to take control of affected systems and launch supply chain attacks, according to researchers from SonicWall. 
    • “Apache OFBiz is an open source enterprise resource system that is used in a wide range of software, including Atlassian Jira, which is used by more than 120,000 companies. “Jira uses a customized OFBiz Entity Engine that does not implement the vulnerable framework module,” a spokesperson for Atlassian told Cybersecurity Dive via email.
    • “The authentication bypass vulnerability, listed as CVE-2023-51467, has a CVSS score of 9.8 and could expose sensitive data or allow an unauthenticated attacker to execute arbitrary code.”

From the ransomware front,

  • Here’s a link to the Bleeping Computer’s Week in Ransomware.

From the cyber defenses front,

  • The Wall Street Journal offers tips for security computers for personal and small business use.
  • An ISACA expert explains,
    • “As the digital realm continues to expand, it is axiomatic that cybersecurity threats are escalating concurrently. The fight against cybercrime has transformed from an optional frontline battle to a mandatory survival skill for businesses and individuals. Unfortunately, humans have now surpassed machines as the most favored targets for cybercriminals. An effective approach that merges change management methodology with cybersecurity procedures is needed to combat this.”
  • Security Intelligence offers a wholisitc approach to information and operational technology.

Friday Factoids

David Ermer–COVID-19, FDA, Government Contracting, Medical / Rx research, Mental health care, Obesity, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington DC,

  • Govexec informs us,
    • “According to the Biden administration’s quarterly update of its progress in fulfilling the President’s Management Agenda, released last month, the White House is keeping pace with its stated goals of strengthening the federal workforce and modernizing customer experience. 
    • “The latest Performance.gov post touts 5,800 new hires targeted for roles created by the Bipartisan Infrastructure Law and promises eight new pooled hiring efforts to support multi-agency hiring in fiscal 2024, amid other milestones situated across multiple strategy goals. 
    • “Likewise, the goal of making it easier for the public to interact with the federal government’s life experience services is progressing with the stand-up of several pilot programs, and its High Impact Service Providers are aligning operations and workforce capacity to eventually begin reporting customer feedback data.” 
  • BioPharma Dive reports,
    • “For the first time, the Food and Drug Administration has authorized a U.S. state to import prescription drugs from Canada, granting Florida preliminary clearance to bulk purchase medicines from wholesalers there.
    • “The decision is a major policy shift for the agency, which has long resisted drug importation efforts on grounds that it couldn’t ensure the safety and supply of medicines shipped from abroad. Supporters have argued that importing drugs from Canada, where medicines cost far less than in the U.S., could help rein in pharmaceutical costs. * * *
    • “The pharmaceutical industry, which has vehemently opposed importation plans, may also sue to block Florida’s plan.
    • “We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan,” a spokesperson for the industry lobby PhRMA said in an email. “PhRMA is considering all options for preventing this policy from harming patients.”
  • Note the FEHBlog is ambivalent about this decision.
  • The Federal Times discusses a contract protest related delay in implementing new TRICARE contracts.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Covid is surging again, four years after the pandemic began, as a new virus subvariant becomes dominant in the U.S. and as people gather indoors to escape cold weather.
    • “Rising wastewater virus levels and hospitalizations underscore the latest winter Covid surge. One driver is JN.1, the latest offshoot of the virus to take over in the U.S. and an Omicron subvariant. The Centers for Disease Control and Prevention on Friday estimated that JN.1 represents roughly 62% of cases nationwide.
    • “The good news is measures of severe illness—hospitalizations and deaths—remain below last winter’s highs and far lower than the pandemic’s peaks. But the virus remains dangerous for some and a major nuisance for many as people return to work and school after holiday breaks.
    • “The world has seen a steady cycle of new Omicron subvariants ever since that offshoot rapidly took over more than two years ago. When new versions become dominant, it indicates that they have some advantage, whether through their ability to evade immune defenses or easily spread from person to person.”
  • The FEHBlog credits Omicron for being an upper respiratory infection, which is much less dangerous than the initial waves of Alpha and Delta Covid, which were lower respiratory infections.
  • The CDC’s FluView notes,
    • “Seasonal influenza activity is elevated and continues to increase in most parts of the country.
    • “Outpatient respiratory illness has been above baseline1 nationally since November and is above baseline in all 10 HHS Regions.
    • “The number of weekly flu hospital admissions continues to increase.
    • “During Week 52, of the 651 viruses reported by public health laboratories, 581 (89.2%) were influenza A and 70 (10.8%) were influenza B. Of the 342 influenza A viruses subtyped during Week 52, 300 (87.7%) were influenza A(H1N1) and 42 (12.3%) were A(H3N2).”
  • Behavioral Health Business discusses
    • “How Fentanyl has changed Opioid Use Disorder Treatment,”
  • and
    • “Top behavioral health trends for 2024.”
  • The American Medical Association offers top health tips obesity medicine physicians want you to know.
  • The National Institutes of Health Director announced in her blog,
    • “Nearly 35 million people in communities across the U.S. have type 2 diabetes (T2D), putting them at increased risk for a wide range of serious health complications, including vision loss, kidney failure, heart disease, stroke, and premature death.1 While we know a lot about the lifestyle and genetic factors that influence diabetes risk and steps that can help prevent or control it, there’s still a lot to learn about the precise early events in the body that drive this disease.
    • “When you have T2D, the insulin-producing beta cells in your pancreas don’t release insulin in the way that they should. As a result, blood sugar doesn’t enter your cells, and its levels in the bloodstream go up. What’s less clear is exactly what happens to cause beta cells and the cell clusters where they’re found (called islets) to malfunction in the first place. However, I’m encouraged by some new NIH-supported research in Nature that used various large datasets to identify key signatures of islet dysfunction in people with T2D.”
  • The NIH further announced,
    • “Semaglutide, a highly popular medication approved by the U.S. Food and Drug Administration to treat obesity and manage type 2 diabetes, was associated with a 49% to 73% lower risk of first-time or recurring suicidal ideations compared to other medications for controlling obesity and type 2 diabetes that work via different mechanisms. These findings provide evidence that semaglutide – which helps regulate appetite and insulin levels by targeting glucagon-like peptide 1 receptors (GLP1R) in the body – does not appear to increase the risk of suicidal ideation, contrary to the claims of some anecdotal reports. Published today in Nature Medicine and paired with a related Research Briefing(link is external), the study was co-led by scientists at Case Western Reserve University and the National Institute on Drug Abuse (NIDA), National Institutes of Health.”
  • Per the American Medical Association,
    • “The AP (1/4, Neergaard) reports, “Seizures during sleep are a potential cause of at least some cases of sudden unexplained death in childhood, or SUDC, researchers at NYU Langone Health reported Thursday after analyzing home monitoring video that captured the deaths of seven sleeping toddlers.” The study “offers the first direct evidence of a seizure link,” although “scientists also have found that a history of fever-related seizures was about 10 times more likely among the children who died suddenly than among youngsters the same age.” The findings were published in the journal Neurology.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “The cost of treating a COVID-19 hospital patient in the hospital rose by 26% over the first two years of the pandemic, more than five times the rate of medical inflation during that time, according to a newly published analysis of 1.3 million admissions.
    • “On average and after adjustments, direct treatment costs for a COVID-19 hospital admission rose from $10,394 in March 2020 to $13,072 in March 2022, a gain that researchers said landed alongside increased use of breathing assistance machines.
    • “Such technologies proved to be costly; stays in which a COVID-19 patient required extracorporeal membrane oxygenation (ECMO), for instance, averaged $36,484 and increased by 35% over the course of the study period, they wrote in JAMA Network Open.
  • Forbes reports,
    • “Health insurance giant Elevance Health said it has agreed to acquire Paragon Healthcare, Inc., a provider of infusion services to patients.
    • “Elevance said Paragon provides infusion services to patients through its “omnichannel model of ambulatory infusion centers, home infusion pharmacies, and other specialty pharmacy services.” Financial terms of the deal for privately held Plano, Texas-based Paragon were not disclosed.
    • “It’s the latest effort by Elevance Health to bolster its specialty pharmacy business and pursue its strategy to treat the whole health of the person. Last year, Elevance Health, which operates Blue Cross and Blue Shield health plans in 14 states, closed on its acquisition of BioPlus, a specialty pharmacy.”
  • Healthcare Dive reports,
    • “Tom Cowhey, a financial executive at CVS who stepped into the interim CFO role late last year, has been permanently named to the post, the company announced on Friday.
    • “In October, Cowhey replaced Shawn Guertin, who served as CFO and president of health services. Guertin, who has been on a leave of absence due to family health reasons, will now officially leave CVS later this year, the company said. 
    • “Cowhey joined CVS in early 2022 after previously serving as CFO of Surgery Partners. Before that, he worked at Aetna in strategy and finance positions, before the health insurer was acquired by CVS.”
  • The American Medical Association lets us know,
    • “Significant changes in the Current Procedural Terminology (CPT®) code set for immunizations reflect the changing nature of how COVID-19 is being addressed as actions transition from a public health emergency response to combatting emerging variants much like the flu.
    • “One significant change involves the consolidation of more than 50 previous codes to streamline reporting of immunizations for COVID-19. A new vaccine-administration code, 90480, was approved for reporting the administration of any COVID-19 vaccine for any patient. This replaces all previously approved, product-specific vaccine-administration codes. * * *
    • “Additionally, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), an advisory group of the FDA, recommended that the COVID-19 vaccine for the 2023–2024 vaccination season be a monovalent vaccine that contains the XBB.1.5 strain, and noted that a number of COVID-19 vaccine products will no longer be recommended for use. The streamlined structure brings greater alignment between CPT and the current COVID-19 vaccine reporting environment.
    • “The new coding system will allow for new vaccines for new variants whenever they come up without having to do a new code,” said Samuel “Le” Church, MD, MPH, a member of the CPT Editorial Panel and vice-chair of its Immunization Coding Caucus.”
  • Mercer Consulting offers seven breakthrough benefit strategies to explore this year.

Midweek Update

David Ermer–CDC, COVID-19, Federal employment benefits, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–
Thanks to ACK15 for sharing their work on Unsplash.

From Washington, DC

  • Govexec informs us,
    • “A new website has made available a database of anyone serving in a top-ranking position in the federal government, offering new insight that advocates said will boost transparency and better prepare new administrations to transition into power.  
    • “The Office of Personnel Management launched the site to comply with the Periodically Listing Updates to Management (PLUM) Act, which so far includes the names, roles and pay levels of more than 8,000 executives in government.
    • “OPM said that figure will grow to 10,000 as it ensures compliance and updates the list over the coming months. It will include senior leaders at every federal agency, including all 4,000 political appointees, Senior Executive Service members and other top or non-competitively appointed officials. “
  • The Department of Health and Human Services tells us,
    • On Wednesday, January 3, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra met virtually with long-term care facility (LTCF) leaders to express concerns about low vaccination rates among nursing home residents and remind industry leaders of their obligations to offer the COVID-19 vaccine to residents and staff.
    • Today’s conversation was a follow-up call from a previous HHS virtual meeting on December 21 with LTCF leaders to discuss the Centers for Disease Control and Prevention’s (CDC) December 2023 report finding that just 33% of long-term care facility residents were up to date with their COVID-19 vaccinations. The Centers for Medicare & Medicaid Services (CMS) requires all nursing homes to offer COVID-19 vaccines to residents and staff and educate them on their benefits.
  • FedWeek notes,
    • “Fraud against the federal retirement program is continuing, an inspector general report has said, with lack of reporting to OPM on the deaths of beneficiaries the most common means.
    • “These unreported deaths may allow payments to continue because of program vulnerabilities or intentional fraud on the part of bad actors. Sometimes, CSRS or FERS improper payments continue for years and cost tens of thousands of dollars before discovery,” says the IG’s latest summary of its investigative activities.”
  • FEHBlog note — The government needs a better system to keep track of deaths.

From the U.S. public health and medical research front,

  • The New York Times reports,
    • “The holidays have come and gone, and once again Americans are riding a tide of respiratory ailments, including Covid. But so far, this winter’s Covid uptick seems less deadly than last year’s, and much less so than in 2022, when the Omicron surge ground the nation to a halt.
    • “We’re not seeing the signs that would make me think that we’re heading into another severe wave,” said Caitlin Rivers, an epidemiologist at the Johns Hopkins Center for Health Security. “So far, we’re in relatively good shape.”
    • “Still, * * * just a fraction of the most vulnerable people have received the latest Covid shots, she noted.
    • “It’s not too late,” Dr. Rivers added. “We have not even reached peak yet for Covid, and once you reach peak, you still have to get down the other side.” That leaves plenty of time for the vaccine to provide some protection.”
  • Beckers Hospital Review adds,
    • “COVID-19 and flu admissions continue to climb across the country, with the majority of states now reporting high levels of respiratory virus activity. 
    • “Overall, 31 states reported high levels of respiratory virus activity for the week ending Dec. 23. Included in this total are a growing number of states seeing “very high” activity levels: Alabama, California, Colorado, Georgia, Louisiana, Mississippi, Nevada, New Jersey, New Mexico, North Carolina, South Carolina, Tennessee, Virginia and New York City. Two weeks ago, just five states reported very high levels.” 
  • Medscape notes
    • “While COVID has now claimed more than 1 million lives in the United States alone, these aren’t the only fatalities caused at least in part by the virus. A small but growing number of Americans are surviving acute infections only to succumb months later to the lingering health problems caused by long COVID.
    • “Much of the attention on long COVID has centered on the sometimes debilitating symptoms that strike people with the condition, with no formal diagnostic tests or standard treatments available, and the effect it has on quality of life. But new figures from the US Centers for Disease Control and Prevention (CDC) show that long COVID can also be deadly.
    • “More than 5000 Americans have died from long COVID since the start of the pandemic, according to new estimates from the CDC.”
  • STAT News alerts us,
    • “One in three heart patients live with anxiety, depression, and ongoing stress, according to a 2023 meta-analysis of over 100 studies. But even in the age of 24/7 monitoring via implantable loop recorders and wearables, many patients are without professional support for the mental and emotional social aspects of coping with heart disease.
    • “The technology of cardiology is locked down. People get that. What’s not locked down is the patient experience,” said Sam Sears, professor of health psychology at East Carolina University, and the author of over 200 research studies on psychological interventions for heart health. “The human factors in all this just don’t get addressed as a standard of care.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Cigna is in advanced talks to sell its Medicare business in an about-face for the health-insurance giant, which had been expanding its footprint in the fast-growing sector. 
    • “Cigna, which has been running an auction for the business, known as Medicare Advantage, is now in exclusive talks to sell it to Health Care Service Corp. for between $3 billion and $4 billion, according to people familiar with the matter. 
    • “Should there be a deal, it would mark a major expansion for HCSC, a big nonprofit health insurer that is the parent of Blue Cross Blue Shield plans in five states including Texas and Illinois. HCSC has long been a powerful player in its home states, but the deal would give it a significant Medicare business and far broader reach. Cigna is offering Medicare plans in 29 states for 2024.
  • Drug Channels offers its annual “reality check on U.S. drug pricing.”
  • Per Fierce Healthcare,
    • “Solera Health, a chronic condition management platform for payers and employers, is expanding its platform to include virtual specialty care facilitated by several new clinical partners.
    • “Solera’s HALO Platform is an omni-condition management tool that aims to address high-cost chronic conditions, mostly serving commercial populations. The latest expansion into virtual specialty care furthers the company’s value-based care mission by widening access to specialist docs in a low-cost setting, executives told Fierce Healthcare.
    • “The new capabilities leverage partnerships with two new partners, 9am.health and Vori Health, as well as an existing partner, Oshi Health.
    • “Each partner specializes in addressing high-cost conditions, from obesity and diabetes to musculoskeletal pain to GI conditions. They offer a health coach, nutritionist, peer support and other support services while also coordinating with a patient’s primary or in-person care doc.”
  • Health Payer Intelligence looks at employer-sponsored plan trends for 2024.

Tuesday Tidbits

David Ermer–FDA, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The U.S. Census Bureau informs us,
    • “[T]he U.S. population [was projected to be] 335,893,238 on New Year’s Day, an annual increase of 1,759,535 or 0.53%.
    • “In January 2024, the United States is expected to experience a birth every 9.0 seconds and one death every 9.5 seconds. Meanwhile, net international migration is expected to add one person to the U.S. population every 28.3 seconds. The combination of births, deaths and net international migration increases the U.S. population by one person every 24.2 seconds.
    • “The projected world population on Jan. 1, 2024, is 8,019,876,189, up 75,162,541 (0.95%) from New Year’s Day 2023. During January 2024, 4.3 births and 2.0 deaths are expected worldwide every second.”
  • The Internal Revenue Service released the Employers’ Tax Guide to Fringe Benefits for use in 2024.
  • Federal News Network discusses four ways federal pay practices have changed for 2024.
  • The Food and Drug Administration accounts for its recent actions.

From the public health and medical research front,

  • Medscape explains the other health conditions, besides diabetes and obesity, that GLP-1 drugs might treat. It’s an impressive list.
  • STAT News reports,
    • “Reducing or eliminating alcohol consumption reduces the risk of developing oral cavity and esophagus cancers, according to a special report from the International Agency for Research on Cancer. But more data are needed to conclude whether the same is true for several other cancer types, including colorectal, breast, and liver cancer.
    • “Even so, it is likely that reducing or ceasing to drink alcohol will lessen the risk of these cancers, said Farhad Islami, a cancer epidemiologist at the American Cancer Society and an author of the report. “Given that many of these cancers have similar mechanistic pathways, we think we will see a similar association with reduction or cessation,” he said. “That’s why we recommend more studies, so we can have stronger evidence.”
  • BioPharma Dive points out ten clinical trials that are worth watching in the first half of 2024.

From the U.S. healthcare business front,

  • Healthcare Dive tells us,
    • “BJC HealthCare and Saint Luke’s Health System closed their merger on Monday, about seven months after the Missouri-based systems announced plans to combine.The combined organization will operate under the BJC HealthCare brand in its eastern region, serving St. Louis and southern Illinois. The Kansas City region will retain the Saint Luke’s brand name. The new system has a combined workforce of 44,000 employees, according to a Tuesday announcement.”
  • MedTech Dive notes,
    • “Roche reached an agreement to acquire LumiraDx’s point-of-care testing technology, the companies announced on Dec. 29.
    • “Roche will pay $295 million upfront and an additional amount up to $55 million to fund Lumira’s point-of-care technology platform business until the acquisition closes. 
    • “The acquisition comes as Lumira faces a potential delisting amid declining revenue.”
  • Health Payer Intelligence identifies trends in health insurer strategies for 2024. “In 2024, payer strategies will include improving health equity partnerships, differentiating their Medicare Advantage plans, and offering care navigation.”
  • Healthcare IT News offers an interview with “[t]wo investment bankers discuss the players in the telehealth sector, the main financial backers, the dynamics between venture capital and private equity, and more.
  • Beckers Hospital Review tells us,
    • “Feeling blue? Your employer might have an AI app for that, The Wall Street Journal reported Dec. 27. 
    • “Workplaces increasingly are offering employees access to digital mental health tools, including AI chatbots meant to mimic therapists and wellness apps that diagnose mental health conditions, the report said. Over the summer, a survey of 457 U.S. companies conducted by professional services company WTW found that about one-third offer a “digital therapeutic” for mental health support. Another 15% were considering adding one by 2025. 
    • “The capabilities and goals of these services vary. Amazon gives employees free access to the app Twill, which uses AI to track users’ moods and create “personalized mental-health plan(s).” A construction workers’ union in Ohio will begin offering access to Wysa, a self-described “emotionally intelligent” AI chatbot that encourages users to “vent or just talk through negative thoughts and emotions” and “let it help you cope with pandemic anxiety and lockdowns.” 

Friday Factoids

David Ermer–CDC, Mental health care, OPM, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Federal News Network informs us
    • “As part of a big push from the Biden administration to conduct a governmentwide AI hiring surge, the Office of Personnel Management is trying to make it easier for agencies to recruit experts in the field.
    • “OPM has authorized direct hire authority for a handful of governmentwide occupations — IT specialist, computer scientist, computer engineer, and management and program analyst — according to a memo the agency published Friday.
    • “This authorization will assist agency efforts to increase AI capabilities in the federal government,” OPM said in the memo.”
  • The Washington Post explores efforts to improve access to primary care in the US.
    • “Primary care is one of the few interventions that has been shown to improve health outcomes,” said Shantanu Nundy, a primary care physician who works for a virtual care company and at a federally qualified health center. The current system devalues routine preventive care in favor of expensive treatments, he said, and “Americans are living poorer-quality and shorter lives as a result.” * * *
    • “In September, Sens. Bernie Sanders (I-Vt.) and Roger Marshall (R-Kan.) announced a $26 billion legislative bill aimed at expanding primary care and reducing staffing shortages. The impact of that bill is likely to be limited, partly because it is focused almost exclusively on federally qualified health centers, which cater to less than 10 percent of the population, while the problems with primary care are far more extensive.
    • “The HHS initiative also does not change an essential flaw in the current financial structure, which relies on a physician visit to initiate the billing process. If a community health worker first knocks on somebody’s door, there is no way to reimburse that visit. Those problems became clearer during and after the pandemic, which put a spotlight on how few people have a lasting relationship with a primary care doctor. The challenge is to figure out ways to pay for entry-level services and care providers beyond the family doctor.
    • “Given the shortages and trust issues, it makes much more sense for people to be allowed to see those other health professionals first,” Nundy said. “The whole system bottlenecks on the physician.”
    • FEHBlog note: So PCP gatekeepers are now bottlenecks.

From the public health front,

  • The Centers for Disease Control’s Fluview tells us,
    • “Seasonal influenza activity is elevated and continues to increase in most parts of the country.
    • “Outpatient respiratory illness is above baseline1 nationally for the eighth consecutive week and is above baseline in all 10 HHS Regions.
    • “The number of weekly flu hospital admissions continues to increase.
    • “During Week 51, of the 875 viruses reported by public health laboratories, 748 (85.5%) were influenza A and 127 (14.5%) were influenza B. Of the 391 influenza A viruses subtyped during Week 51, 309 (79.0%) were influenza A(H1N1) and 82 (21.0%) were A(H3N2).”
  • Medscape points out,
    • “The COVID-10 pandemic may no longer be a global public health emergency, but millions continue to struggle with the aftermath: Long COVID. New research and clinical anecdotes suggest that certain individuals are more likely to be afflicted by the condition, nearly 4 years after the virus emerged. 
    • “People with a history of allergies, anxiety or depression, arthritis, and autoimmune diseases and women are among those who appear more vulnerable to developing long COVID, said doctors who specialize in treating the condition.”
  • STAT News reports on three addiction stories to watch next year:
    • Will methadone access expand?
    • Will there be a return to police-first drug policy?
    • Will telehealth be given a role in recovery?
  • The American Medical Association tells us what doctors wish their patients knew about their family health history.

From our U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Though often associated with gaming, virtual reality (VR) is a technology rapidly evolving in healthcare. From pain management to enabling more efficient surgeries to gamifying physical therapy, VR use cases continue to proliferate. 
    • “It especially holds promise in revolutionizing the behavioral health space, with substantial research supporting its effectiveness. VR is being used to treat a number of conditions, including anxiety, post-traumatic stress disorder (PTSD), substance use disorders and autism.
    • “VR therapy is not a new concept. It was formally studied more than two decades ago, though it wasn’t until the last few years that the field became prominent, with new companies moving into the space. And as technology has improved and gotten more intuitive to use, it has also become less expensive. And in 2022, the American Medical Association approvedthe first-ever CPT code for VR-mediated therapy. 
    • “There is no question mark in my view about the clinical validity and clinical value the technology can bring to the market,” Eran Orr, CEO at XRHealth, told Fierce Healthcare, pointing out there are more than 15,000 published papers on VR’s efficacy across modalities.
    • “Not only can VR expand a provider’s arsenal of treatment tools, Orr said, but it also offers a wealth of insights on engagement, biofeedback, wellness and other data. “VR is the technology for mental health,” Orr said.
    • “Despite its potential, the technology still faces hurdles to adoption, like reimbursement, logistical challenges and regulatory pressures.” 
  • Beckers Hospital Review shares the top ten trending Google health searches of 2023 with us.

Tuesday Tidbits

David Ermer–Congress, Medical / Rx research, Mental health care, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Federal News Network informs us
    • “Agencies don’t have to worry about a 1% sequestration on discretionary funds kicking in for a few more months.
    • “The Office of Management and Budget says the requirement to reduce discretionary spending under the Fiscal Responsibility Act (FRA), signed into law in June, wouldn’t take effect until “after full year appropriations are enacted, or April 30, whichever comes first.”
    • “OMB will take no action on Jan. 1, 2024, and no additional action should be taken by agencies to reduce impacted discretionary funding, even though a short-term continuing resolution will be in effect at that time,” OMB wrote in frequently asked questions on 2024 discretionary spending sent to agencies on Dec. 22. “If any discretionary appropriation account remains on a short-term CR past April 30, OMB is required to issue a final sequestration report that compares the annualized appropriation levels provided by all discretionary appropriations bills under current law as of April 30 against the [FRA’s] section 102 interim spending limits. A breach of the section 102 spending limits would require OMB to order a sequestration to bring the current law discretionary appropriations in line with those interim spending limits.”
  • Govexec identifies the federal agencies with the greatest increases and decreases in employee morale in 2023 according to OPM’s 2023 Federal Employee Viewpoint Survey.
  • Fedweek offers a summary of OPM’s current regulatory activities.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Immune-boosting drugs have revolutionized cancer care. Now doctors are experimenting with cutting them off.  
    • “Immunotherapies unleash the immune system on tumors. They have extended the lives of people with melanoma, lung and bladder cancers. They have also been a boon for drugmakers, generating global sales of $44 billion in 2022, according to Leerink Partners analysts. 
    • “But some patients are getting more of the drugs than they need, exposing them to side effects and costs they could avoid without risking their cancer recurring. Preliminary research suggests taking the drugs at a lower dose or for a shorter period could be sufficient, but drugmakers haven’t funded the studies needed to confirm the findings. 
    • “We don’t know when to stop,” said Dr. Jedd Wolchok, an oncologist focused on melanoma at Weill Cornell Medicine in New York. * * *
    • “Recalibrating care toward less treatment is a fraught undertaking. Drug companies won’t fund studies exploring whether patients can do as well with less of their products, doctors said. Some doctors and patients worry about pulling back before exhausting their best chance to beat the disease.
    • “There was this dogma that more is better,” said Dr. Mark Ratain, an oncologist at the University of Chicago. 
    • “He is trying to recruit cancer patients to study whether they could do as well with less of Merck’s Keytruda or Bristol-Myers Squibb’s Opdivo, so-called immune checkpoint inhibitors. After three years, he has found just 60 of the 260 patients he wants, and most medical centers have declined to join the trial. “It was going to be difficult to convince people,” he said.”
  • Beckers Payer Issues interviews Kofi Essel, MD, Elevance Health’s first food as medicine program director. Dr Essel “sat down with Becker’s to discuss how Elevance is building a food as medicine strategy intended to eventually touch and improve the lives of its more than 47 million members nationwide.” Check it out.
  • MedPage Today tells us,
    • “The 988 lifeline routes callers to a network of more than 200 state and local call centers that are financially supported by the Substance Abuse and Mental Health Services Administration (SAMHSA), as well as state and local governments. In its first year, according to a July press release from SAMHSA, the lifeline answered nearly 5 million calls, texts, and chats from people looking for help with suicide, mental health, and substance use-related crises; that’s 2 million more contacts than the lifeline received in the previous 12 months, when it was a 10-digit phone number. (That 10-digit number — 800-273-8255 — is still in operation.)
    • “So far, 1.5 years in, things seem to be going well overall, said Michele Gilbert, MPH, senior policy analyst at the Bipartisan Policy Center in Washington, D.C. “Luckily, the implementation of 988 has seen some real success,” Gilbert said in a phone interview. “A lot of the operations have gone relatively smoothly.”
    • “Debbie Plotnick, MSS, executive vice president for state and federal advocacy for Mental Health America, agreed. “We have seen tremendous increases in the number of people who call, and even more importantly, what has improved dramatically is the wait time to speak to an actual human being,” she told MedPage Today. “Going back a couple of years, it could have been up to, like, 2 minutes, and now it’s within 30 or 40 seconds that you are actually connected to a live human being.”
    • “That decrease in wait time may not sound like a lot, but it’s actually “huge,” Plotnick said. “If you’re at the point where you’re going to hurt yourself and you don’t know if anybody in the world cares, 2 minutes can really feel like an eternity. But now calls are being answered very quickly.” She also praised the lifeline’s addition of text and chat options, as well as special lines for veterans, for Spanish speakers, and for LGBTQ+ callers.”

From the U.S. healthcare business front,

  • Beckers Hospital Review points out,
    • “The median hospital operating margin rose to 2% in November after holding steady at 1.6% in September and October, but escalating expenses — including rising drug costs — remain a concern as 2023 draws to a close, according to a Dec. 21 report from Syntellis Performance Solutions, which includes data from more than 1,300 hospitals.
    • “U.S. hospitals began the year with a median operating margin of -0.9%, but that figure has steadily increased and looks set to end the year at a healthier level around the 2% mark in December. November was the ninth consecutive month of positive operating margins. 
    • “While the median hospital margin remains far below pre-pandemic levels, it has shown significant progress in recent months as hospitals continue their recovery after more than a year of negative results. 
  • The Wall Street Journal reports,
    • “Drug company Bristol-Myers Squibb struck a $4.1 billion deal to buy  RayzeBio in a bet on a re-emerging cancer drug technology.
    • “RayzeBio develops radiopharmaceutical drugs, which use targeted forms of radiation that are delivered directly to cancer cells. Earlier products using the technology struggled commercially, but further research led to another wave of promising therapies that can attack tumors while limiting damage to surrounding healthy cells.  * * *
    • “Bristol said the RayzeBio deal is slated to close in the first half of 2024.”
  • and
    • AstraZeneca has agreed to buy Gracell Biotechnologies for a transaction value of $1.2 billion, as part of the former’s efforts to grow its cell therapies business.
    • The acquisition will help grow AstraZeneca’s pipeline of cell therapies for potential treatment of cancer and autoimmune diseases.
    • The transaction is expected to close in the first quarter of next year, AstraZeneca said.